PREMIER VALUE ZINC OXIDE - zinc oxide cream 
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                                                              Purpose

Zinc Oxide 20%.............................................................Skin protectant

Uses

Warnings For external use only

Do not use over deep or puncture wounds, infections or lacerations

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients aloe vera gel, liquid paraffin, tocopherol acetate, white beeswax, white petrolatum

Distributed By

Chain Drug Consortium

3301 NW Boca Raton Blvd. Suite 101

Boca Raton, FL 33431

Made in Korea

image of carton label

PREMIER VALUE ZINC OXIDE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHITE WAX (UNII: 7G1J5DA97F)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-252-001 in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/30/2013
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 4/2013
Document Id: 3dbd86db-de04-44c2-a59f-d5faa6de1d80
Set id: 73cbbe49-5540-40fe-ac87-a5fa7e5fea01
Version: 1
Effective Time: 20130430
 
Chain Drug Consortium, LLC